Whitepapers

Enereductases (EREDs) and ketoreductases (KREDs) are highly selective enzymes that offer greener alternatives to more traditional asymmetric hydrogenation reactions. Enzyme cascades are a powerful way to enable more environmentally friendly and cost-effective synthetic processes for the manufacture of APIs. Here we report the discovery and development of an ERED/KRED biocatalytic cascade to enable efficient installation of the two stereocenters on a cyclohexyl ring for the synthesis of BMS-986278, a potent small-molecule LPA1 antagonist. A combination of protein engineering and process development optimized the cascade, resulting in orders of magnitude improvement over the original cascade proof-of-concept, and an over four-fold reduction in PMI over the first generation non-biocatalytic campaign for synthesis of the fragment. The synthesis of BMS-986278 was honored as a co-winner of the 2023 Peter J. Dunn award for Green Chemistry & Engineering Impact in the Pharmaceutical Industry, in large part because of the sustainability improvements enabled by this enzymatic cascade.

From next-generation biologics to smarter capsule technology and cleaner supplier communication, this ebook brings together 4 insights at where formulation science is headed and what it takes to get complex therapies safely from lab to patient. Inside, readers will find a look into the stability challenges of emerging biologics such as antibody-drug conjugates and bispecifics, including real-world case studies on taming viscosity and solubility at high concentrations. The industry's accelerating shift from IV to subcutaneous delivery is discussed, unpacking the regulatory approvals, patient-outcome data, and market forces turning at-home biologic dosing into standard practice. On the drug-delivery-innovation side, a feature on a novel capsule-in-capsule platform shows how liquid and solid actives can be combined in a single dose to cut pill burden without sacrificing performance. Rounding this eBook out, an IPEC-Americas explainer shows how the Excipient Information Package can replace slow, inconsistent supplier questionnaires with a standardized format that speeds qualification from months to days.

Pharmaceutical R&D teams must accelerate innovation while managing complex scientific data, disconnected research systems, and increasing regulatory expectations. This white paper explores how integrated lab informatics can create a connected digital foundation for research, linking data, workflows, instruments, and teams across the R&D lifecycle. Discover how modern informatics can strengthen collaboration and reproducibility, automate routine processes, and enable more confident, data-driven decisions in drug discovery and development.

Pharmaceutical manufacturing laboratories must maintain reliable data, controlled processes, and regulatory readiness while supporting efficient quality operations. This white paper examines how a purpose-built, pre-validated LIMS can replace manual and disconnected workflows with integrated sample management, instrument connectivity, secure audit trails, and embedded quality-management capabilities. Learn how a modern LIMS can help improve data integrity, streamline laboratory operations, support compliant batch release, and protect product quality.

WHY A PURPOSE-BUILT LIMS? The Data Management Challenge A successful lab is more than a scientific hub. In today’s age, it’s a digital data enterprise. But should that platform be one-size-fits-all across industries? A pharma lab needs regulatory documentation, while a diagnostics lab requires advanced tracking of biospecimens. Traditionally, each would begin with the same basic building blocks: a Laboratory Information Management System (LIMS) with standalone point solutions such as an Electronic Laboratory Notebook (ELN) or a Laboratory Execution System (LES) daisy-chained together to approximate an end-to-end solution. Then, through a complex à-la-carte development and validation process, each of these labs would customize their platform in response to their divergent needs. Until now.

Are you putting your secondary packaging through its paces with 100% vision inspection technology? Learn what it takes to maintain the highest level of quality, as in 100%.

Colbert Packaging Executives Report on the State of the Secondary Packaging Industry and Why Independence Matters

Discover a novel technology to standardize purification across a broad range of microbial proteins that accelerates and streamlines microbial workflows. This new technology addresses a key bottleneck in microbial bioprocessing, enabling predictable, scalable, and accelerated manufacturing of next-generation biologics. Download the white paper to learn more.

Accelerate microbial bioprocess development with proven strategies that shorten timelines. Learn practical methods to de-risk scale-up from gene to GMP without compromising quality whilst enabling rapid, confident progression to robust, scalable and commercially viable processes.

As increasingly complex, poorly water-soluble molecules enter development, AustinPx helps developers look beyond near-term needs and select the right ASD technology for the full program. With spray drying, hot-melt extrusion, and KinetiSol™ under one roof, our team evaluates leading ASD approaches early and, on a drug-specific basis. Through comprehensive screening, optimization, biopharmaceutical analysis, and early manufacturing assessment, we help clients identify the right formulation and process before late-stage commitments are made, reducing the risk of reformulation, clinical delays, PK bridging studies, manufacturing constraints, and rising cost of goods while protecting scalability, patient experience, and long-term asset value.

An educational eBook exploring how continuous environmental monitoring systems help pharmaceutical and biopharmaceutical manufacturers achieve and maintain FDA, GMP, and 21 CFR Part 11 compliance.

A practical checklist walking pharmaceutical and lab quality teams through the seven key considerations for selecting a compliant, scalable, environmental monitoring system.

An educational article on how precise temperature and humidity control protects biopharmaceutical product stability, supports FDA 12 CFR part 11 compliance, and reduces manufacturing risk.

An educational article examining how continuous environmental monitoring protects sample integrity across every phase of the drug development lifecycle, from discovery and preclinical research through clinical trials and post-market surveillance.

This Quality and Regulations eBook, presented by PharmTech, PharmTech Europe, and BioPharm International® is your guide to quality and compliance strategy, covering everything from ICH Q5A(R2)'s viral safety expectations to what a real FDA warning letter reveals about AI's limits in GMP documentation. Industry leaders discuss how risk-based quality frameworks are accelerating biopharma development, alongside a look at how USP's digital standards are modernizing quality control labs without sacrificing rigor. This eBook offers a practical roadmap for building quality systems ready for 2026's regulatory landscape and beyond.

Aseptic processing by design: The flexible and efficient use of RABS and Isolators

Delivering clinical supplies into the European Union and United Kingdom requires rigorous oversight from a QP to ensure every batch meets regulatory, GMP, and trial-specific requirements. Yet, many sponsors face preventable delays, often due to incomplete documentation, limited supply chain visibility, or late communication of changes. This paper breaks down the core responsibilities of the QP, explains how European Union and United Kingdom expectations differ, and share practical steps sponsors can take to streamline the certification process. Readers will learn how to prepare audit-ready documentation, avoid common pitfalls that extend release timelines, and build efficient collaborations with QPs to keep studies moving without interruption.

The development and manufacturing of innovative drug products, particularly those involving protein formulations, nucleotide-based drugs, peptides, and poorly soluble molecules, face significant hurdles. A primary challenge lies in designing scalable manufacturing processes that meet production demands while ensuring stability and bioavailability. Traditional methods often fall short when handling advanced therapeutic modalities, resulting in limitations in production volume, product consistency, and manufacturability. Addressing these limitations is critical to bringing novel therapies to market effectively and at scale. Spray drying has emerged as a scalable and consistent manufacturing process for producing drug product intermediates. This paper explores the use of spray drying to overcome manufacturing bottlenecks and enhance development across a wide range of drug products.

Catalent’s micronization services help innovators overcome the toughest drug development challenges. Our high-containment facilities and expert scientists deliver consistent particle size reduction, high API recovery, and audit-ready processes to support early-phase clinical programs. Whether your project requires potent API handling, rapid turnaround, or extended analytical verification, Catalent combines speed, precision, and compliance to keep your milestones on track. Gain insights into real-world case studies that demonstrate how our structured, transparent approach ensures reliable delivery while protecting your valuable APIs. Discover why leading pharmaceutical and biotech companies choose Catalent as their trusted CDMO partner for micronization.

Pharmaceutical micronization, the process of reducing particle size to the micrometer scale, has become a critical technology for improving drug solubility, bioavailability, and formulation flexibility. Catalent, a global leader in drug development and delivery solutions, offers world-class micronization services through its specialized facilities in Dartford, UK, and Malvern, Pennsylvania, USA, supported by a network of forward processing commercial-scale manufacturing sites. This article explores the advantages of micronization and how Catalent’s integrated approach accelerates drug development.

Modern drug development faces a two-part pressure test: molecules are getting harder to formulate, and global manufacturing routes are getting harder to rely on. Poor water solubility and limited physical stability continue to delay many small-molecule and peptide programs, while shifting trade policies, logistics constraints, and onshoring pressure increase the cost and risk of fragmented supply chains. Sponsors need formulation strategies that improve performance and also translate cleanly to robust, predictable manufacturing. This paper explores how integrating large-scale domestic spray drying capacity earlier in development can accelerate timelines, lower costs, and strengthen portfolio resilience in an unpredictable global landscape. It outlines how this approach supports rapid development, enhances cost efficiency for high-volume therapies, and mitigates risks tied to international manufacturing disruptions.

Understanding the role of secondary packaging as a first line of defense is a key component in the war on counterfeit drugs.

In this white paper, we zoom out with a broader lens to view serialization as part of a broader system to ensure safety in pharmaceuticals.

In today’s Pharma 4.0 world, real-time oversight and digital traceability are critical, forcing manufacturers to reassess efficiencies while advancing quality control and confidence. Binder jet 3D-printing enables advanced process analytics, tablet-level traceability, and continuous monitoring to provide a data-driven approach to pharmaceutical production. By measuring critical quality attributes for every tablet throughout manufacturing, the platform enables continuous process verification, targeted identification of deviations, and reduced waste compared with traditional batch-based quality methods. This integrated foundation supports real-time release while delivering greater transparency, process control, and operational efficiency across the product lifecycle.

Sequence variant analysis is essential for characterizing biotherapeutic proteins, but high rates of false positives can slow development. Subtle yet potentially profound changes to a protein's amino acid sequence can dramatically alter its function and impact patient safety. This paper reveals how low-level posttranslational modifications introduced during protein digestion can be misidentified as sequence variants. By implementing time-course digestion during method development, it can effectively distinguish true variants from artifacts, significantly reducing data analysis time. Case studies also show how to integrate time-course digestion into a workflow.

Liquid nasal drug delivery has evolved from simple local therapies into a highly versatile platform supporting rapid systemic delivery, emergency rescue medications, and emerging CNS-targeted treatments. As these applications expand, successful development increasingly depends on early, integrated alignment of formulation science, device selection, analytical control, and manufacturing strategy. In this article, Catalent experts Dr. Alan Watts and David Wilcox examine the current and emerging nasal delivery landscape and outline critical chemistry, manufacturing, and controls (CMC) considerations across development, scale-up, and commercial production. Drawing on real-world experience, the piece highlights practical strategies to reduce technical risk, support regulatory readiness, and enable robust, scalable liquid nasal drug products.

Poor solubility remains one of the most persistent and costly challenges in pharmaceutical drug development. Inside this eBook you'll find peer-reviewed research and expert perspectives on how AI, machine learning, and molecular dynamics simulations are transforming cyclodextrin-based drug formulation. From a novel nomenclature system that enables AI-driven structural optimization to a landmark case study examining remdesivir's interactions with sulfobutylether-β-cyclodextrins, readers will gain actionable insight into predictive modeling strategies that reduce API waste, accelerate development timelines, and improve the odds of getting complex small molecules to patients.

Discover the benefits of a global CDMO manufacturing strategy built for scale, speed and reliability